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FDA 510(k) Application Details - K012520
Device Classification Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
More FDA Info for this Device
510(K) Number
K012520
Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant
CARDIAC ASSIST DEVICES, INC.
11000 CEDAR AVE., SUITE 451
CLEVELAND, OH 44106-3052 US
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Contact
RASSOLL RASHIDI
Other 510(k) Applications for this Contact
Regulation Number
870.1220
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Classification Product Code
DRF
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More FDA Info for this Product Code
Date Received
08/06/2001
Decision Date
03/27/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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